My Experience

Freelance Consultant – Projects

  • Clinical Evaluation process for external service provider
  • Clinical Evaluation process for CRO
  • Regulatory Strategy and Clinical Evaluation according to MEDDEV 2.7.1 for a resorbable medical device
  • Regulatory Strategy for coated stent
  • Risk Management consultant for manufacturer of dialysis products (leading global harmonization of Risk Management process with interface to
  • Clinical Evaluation process)
  • Regulatory Strategy for pharmaceutical application device
  • Risk Management for HF surgical device
  • Interim Risk Manager and team lead (Disposables for heart-lung machines; Update of 35 risk management files; Implementation of Risk Management tool)
  • Clinical Evaluations according to MEDDEV 2.7.1 for orthopaedic implants
  • Biological Safety Evaluation according to DIN EN ISO 10993-1 for orthopaedic implants
  • Regulatory Strategy for surgical instruments for orthopeadic implants
  • Regulatory Strategy and complete Technical Documentation for CE mark for mobile organizational units

Head of Regulatory Affairs

  • Responsible for all CE-marked medical devices (non-active) of SFM
  • Responsible regulatory affairs contact person for OEM clients from medical device and pharmaceutical industry
  • Responsible for update of all technical documentations
  • Process optimization for risk management
  • Implementation of clinical evaluation and usability engineering processes, as well as standardized procedures for preclinical testing
  • In-house training of colleagues in regulatory affairs topics
  • Strongly involved in implementation of document management system for the whole company
  • Demarcation between drugs and medical devices – Presentation at University of Applied Sciences in Ansbach, Germany
  • RAPS Online University student in dual course for pharmaceuticals, medical devices & combination products (US and EU regulations)
  • Speaker at conferences and seminars on Regulatory & Clinical Affairs (e.g. Forum Institut, BVMed)
  • Speaker at Medica/Compamed 2013 on Safety Protection Devices
  • Member of BVMed working team Regulatory and Political Affairs
  • Member of DIN working groups for quality management and risk management standard

Functional Head Non-active medical devices and Clinical Affairs

  • Responsible Manager for Clinical and Preclinical Affairs with a team of three employees and more than 15 freelance partners
  • Responsible for Clinical Evaluations according to MEDDEV 2.7.1 (Rev.3) for more than 100 different products of more than 50 different manufacturers
  • Clinical Evaluation and Drug Delivery Devices – In-house training and training in cooperation with Forum Institut and APV
  • Planning of Clinical Investigations according to EN ISO 14155 in cooperation with freelance partners
  • Biological Evaluations according to DIN EN ISO 10993-1 and coordination of tests with external labs
  • Technical Documentation, responsible for compilation of 20 technical files for joint implants (higher classification)
  • Expert statements concerning demarcation questions for medical devices and medicinal products
  • Summary Technical Documentation according to GHTF guidance
  • Review of 510(k) for active medical device
  • Support for reimbursement questions in Germany (G-BA and Hilfsmittelverzeichnis)
  • ISO 13485 Training, including QMB, internal auditor and third party auditor
  • Responsible for sales and acquisition for clinical evaluations and related topics
  • Strongly involved in business development of Yes Medical and interface to Yes Pharmaceutical Development Services (mother company)
  • Partly responsible for content of company website and for online marketing of the site
  • Technical Documentation, compilation of 35 technical files for class I, IIa and IIb medical devices
  • Risk Analysis, Risk Management, DIN EN ISO 14971
  • Project management and coordination of a project including 15 team members and including communication with external partners on behalf of the client

Development Engineer

  • Product development: remittance work and in-house development
  • Patent and literature research, preliminary tests and conceptional development, product design and prototyping, support until serial production
  • Product example: Drug transfer systems (e.g.: EasyVial:, PEEK Cage, Liquor-Drainage System, Port-catheter system including port needle, Vertebroplasty syringe, Retractor system for minimal invasive surgery
  • Risk analysis and risk assessment, quality management for medical device manufacturer according to DIN EN ISO 13485
  • Clinical Evaluation including literature search and assessment of publications according to evidence based medicine

My Career


Degree - University of Applied Sciences


Development Engineer


Functional Head


Head of Regulatory Affairs


Freelance Regulatory Affairs Expert

My Skills

Clinical Evaluation

Technical File

Risk Management

Regulatory Strategy

Quality Management



My Values

compliant Clinical Evaluation Reports
MDR Implementation & Readiness
efficient Risk Management
optimized Requlatory Strategy
proactive Post-Market Surveillance
living Quality Management

My Availability

Clinical Evaluation Reports, process implementation & training

upon request

MDR Implementation projects

January 2018

All other projects

upon request

Florian Tolkmitt, Ostendstr. 54, 60314 Frankfurt am Main